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IRCT20220516054874N10 IRCT 2023-08-11 Mashhad University of Medical Sciences Effectiveness of vitamin E on the levels of liver enzymes in patients with high-dose statins-induced hepatic failure Evaluation of the effectiveness of vitamin E on the levels of liver enzymes (ALT and AST) in patients with high-dose statins-induced hepatic failure 2023-08-23 anticipated 56 Complete https://irct.ir/trial/71944 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method is used. The volume of each block will be four. Then the list of blocks is written and numbers assigned to them, for example (AABB(1)- BBAA(2)- BABA(3)- BAAB(4)), which will be 14 blocks according to the sample size of 56. Then random numbers between 1 and 14 are selected according to the randomization site Randomaization.com and finally, the treatment allocation list is determined based on the random numbers, Blinding description: Using sealed envelopes Due to the use of a placebo similar to the intervention treatment, the investigator and the participants will not be informed of the assigned treatment, and the analyst will also be unaware of the assigned treatment for the two groups. Finally, after analyzing the data, the researcher who prepared the packages will reveal the codes A and B. 2 Hepatic failure. Intervention 1: Intervention group: Patients receiving high doses of statins who have increased levels of aminotransferases (ALT or AST) equal to or more than 1.5 times and less than 3 times the upper limit of the normal range and treated with vitamin E tablets at a dose of 200 units once a day for 2 months. Intervention 2: Control group: Patients receiving high doses of statins who have increased levels of aminotransferases (ALT or AST) equal to or more than 1.5 times and less than 3 times the upper limit of the normal range and treated with placebo tablets with the same shape and size once a day for 2 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Vafa Baradaran Rahimi
Ghaeem hospital, Ahmadabad Blvd, Mashhad
Mashhad Iran (Islamic Republic of) 9177948564 0095 5138012739 baradaranrv@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients receiving high doses of statins (Atorvastatin with a dose of more than 40 mg or Rosuvastatin with a dose of more than 20 mg) Abnormalities in liver function tests (increased aminotransferase level equal to or more than 1.5 and less than 3 times the upper limit of the normal range) Consent to admission to the study No previous medical history of liver disease or elevated aminotransferase before statin initiation 18 years no limit Both Receiving other drugs that may affect the increase of liver enzymes Elevation of LFT equal to or greater than 3 times K72 Hepatic failure, not elsewhere classified Treatment - Drugs Placebo Intervention group: Patients receiving high doses of statins who have increased levels of aminotransferases (ALT or AST) equal to or more than 1.5 times and less than 3 times the upper limit of the normal range and treated with vitamin E tablets at a dose of 200 units once a day for 2 months. Control group: Patients receiving high doses of statins who have increased levels of aminotransferases (ALT or AST) equal to or more than 1.5 times and less than 3 times the upper limit of the normal range and treated with placebo tablets with the same shape and size once a day for 2 months. Changes in ALT levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit. Changes in AST levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit. Changes in CBC diff. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit. Changes in lipid profile levels. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit. Changes in hs-CRP serum level. Timepoint: At the beginning of the study and after 8 weeks of treatment. Method of measurement: Laboratory kit. Mashhad University of Medical Sciences Approved 2023-05-22 Research Ethics Committee of Imam Reza Hospital Educational, Research and Treatment Center, Mashhad Imam Reza Hospital educational complex building, Imam Reza Hospital, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)